The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.

NCT ID: NCT02235103

Last Updated: 2016-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-03-31

Brief Summary

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Recent research has revealed that subtle abnormalities can be found in sperm samples that seem to be normal with conventional analysis techniques. The DNA in the sperm heads is sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained infertility do not achieve pregnancy.

We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples with previously unexplained infertility. In a first treatment cycle with intra-uterine insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the results of the patients who are pregnant will be compared with those of the not pregnant ones. We expect to find differences between both groups.

100 patients will be included in the study.

Detailed Description

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Conditions

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Unexplained Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinical Pregnancy

Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination.

Sperm Chromatin Dispersion Test

Intervention Type OTHER

No Clinical Pregnancy

Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination.

Sperm Chromatin Dispersion Test

Intervention Type OTHER

Interventions

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Sperm Chromatin Dispersion Test

Intervention Type OTHER

Other Intervention Names

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Halosperm®

Eligibility Criteria

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Inclusion Criteria

* Unexplained infertility, i.e. female patients with ovulatory cycles and patent tubes; normal sperm analysis (WHO criteria).
* Patient agrees to have a first treatment cycle with intra-uterine insemination and ovulation-induction with clomiphene citrate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Vandekerckhove, MD

Role: PRINCIPAL_INVESTIGATOR

Fertility Centre, University Hospital Ghent

Locations

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Fertility Centre of the University Hospital

Ghent, East Flanders, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B670201316616

Identifier Type: -

Identifier Source: org_study_id

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